- Provide Strategic Leadership and direction for critical assessment and implementation of pivotal stage ready Clinical Trial Quality System. Implement GCP focused auditing, SOP development, Clinical Training, Quality Event Management, CAPA and continuous improvement
- Develop and Implement Risk Based process for GCP and GLP vendor/supplier qualification and Approved Vendor List (AVL) management.
- Establish GCP quality metrics and advise and participate in Clinical Quality metrics and goals for Quality Management Review.
- Provide cross-functional guidance and leadership to GCP functions based on interpretation of current regulations to ensure best practices including risk-based management.
- Partner with Clinical Operations and other GCP-related departments, as applicable, to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues in a timely manner, including approval of corrective action/preventative action (CAPA) plans, as necessary.
- GCP Quality Lead assigned to appropriate Cross-Functional Governance Meetings. Member of Clinical Leadership Team.
- Direct, manage, oversee, conduct and/or assist in internal audits (systems, processes, vendors, computer system validation). Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of corrective actions.
- Collaborate with Clinical Operations/GCP functions with the development and management of key vendor oversight activities for clinical trials and monitor/evaluate the oversight activities.
- Provide functional review of clinical protocols, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.
- Implement Inspection Readiness program and provide leadership to GCP functions for inspection readiness training, preparation, MOCK BIMO interview/audits.
- Collaborate with applicable departmental heads to identify clinical trial and regulatory training needs of Clinical Operations (and other Clinical trial members) based on regulatory changes, process/system changes, audit findings, trends, etc., and assist in coordinating the training to meet the needs. Approve training courses for each role and approve changes to course as needed.
- Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management.
- Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.
- Assist and advise with training QA and clinical staff as necessary for GCP.
- Lead FDA BIMO and other RA clinical sponsor inspections
- Ability to travel domestic and international.
- Assist the Quality Unit with tasks related to GMP activities when required.
- BS in a life science field required.
- At least 15 years of direct GCP pharmaceutical/biotechnology experience.
- Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R2 as well as Canadian trial regulations
- RQA-GCP certification desired
- Direct experience with Global CRO oversight and Global Inspection Preparation/Readiness and Inspection Hosting.
- Excellent written and oral communications skills
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments.
- Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
- The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- Understanding of the drug and biologic development and clinical research processes
- General understanding of non-clinical research and manufacturing processes including terminology
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing.
- Working knowledge of cGMP processes and relevant regulations is a plus.
-
Director, Gcp Operational Quality
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · GENERAL: · The Director, GCP Compliance is responsible for the escalation and management and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these ...
-
Director, GCP Quality
1 week ago
Aura Biosciences Brighton, United StatesAbout Aura Biosciences · Aura Biosciences is a clinical- stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer. Our lead candidate bel-sar is in late-stage clinical development for the tr ...
-
Sr Program Manager, Quality GCP
3 weeks ago
BioSpace, Inc. Watertown, United StatesJob Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key t ...
-
Sr. Manager GCP quality Assurance
1 week ago
Planet Pharma Watertown, United StatesJob Description: · Interested in this role You can find all the relevant information in the description below. · Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance suppo ...
-
Sr Program Manager, Quality GCP
4 weeks ago
AbbVie Watertown, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
-
Sr Program Manager, Quality GCP
4 weeks ago
AbbVie Watertown, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic area ...
-
Director, GCP Quality Assurance
2 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Senior Director Clinical Quality, GCP
4 days ago
Merus Cambridge, United StatesSenior Director Clinical Quality, GCP · Application Deadline: · 21 June 2024 · Department: · Clinical Operations · Employment Type: · Full Time · Location: · Cambridge, MA · Description · We are on the lookout for an experienced Clinical Quality Director, GCP. · In thi ...
-
Manager / Senior Manager, GCP Quality
2 weeks ago
Alkeus Pharmaceuticals Inc Cambridge, United StatesAbout Alkeus Pharmaceuticals: · Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigationa ...
-
Senior Director Clinical Quality, GCP
2 weeks ago
Merus Cambridge, United StatesSenior Director Clinical Quality, GCP · Application Deadline: 21 June 2024 · Department: Clinical Operations · Employment Type: Full Time · Location: Cambridge, MA · Description · We are on the lookout for an experienced Clinical Quality Director, GCP. · In this role you wi ...
-
Manager / Senior Manager, GCP Quality
3 weeks ago
Alkeus Pharmaceuticals, Inc. Cambridge, United StatesAbout Alkeus Pharmaceuticals: · Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigationa ...
-
Manager / Senior Manager, GCP Quality
3 weeks ago
Alkeus Pharmaceuticals Inc Cambridge, United StatesAbout Alkeus Pharmaceuticals: · Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigation ...
-
Senior Manager, GCP Quality Assurance
3 weeks ago
Planet Pharma Cambridge, United StatesSummary of Position: · Playing a critical role, the Sr Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Sr Manager, GCP Quality Assurance coordinates GCP Complian ...
-
Senior Manager, GCP Quality Assurance
3 weeks ago
Bicycle Therapeutics Limited Cambridge, United StatesCompany DescriptionBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted i ...
-
Senior Manager, GCP Quality Assurance
2 weeks ago
Bicycle Therapeutics Limited Cambridge, United StatesCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-target ...
-
Senior Director, GCP Quality Assurance
3 weeks ago
Scholar Rock Cambridge, United StatesScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and ...
-
Senior Manager, GCP Quality Assurance
3 weeks ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists ...
-
Senior Manager, GCP Quality Assurance
1 week ago
Bicycle Therapeutics Cambridge, United StatesJob Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...
-
Planet Pharma Watertown, United StatesWe are working with a Boston area clinical-stage pharmaceutical client looking to hire a full time Senior Manager, Clinical Quality Assurance, GCP. This person will support cross functional teams and external vendors and provide GCP compliance and issue resolution. The role will ...
-
Sr. Manager GCP quality Assurance
1 week ago
Planet Pharma Waltham, United StatesJob Description: · Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP ...
Director, GCP Quality - Brighton, United States - Aura Biosciences
Description
Job Description
Job DescriptionSalary:About Aura Biosciences
Aura Biosciences is a clinical- stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer.
Summary:
The ( Sr) Director GCP Quality Assurance provides Strategic Leadership and Directs all activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Aura Biosciences. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to internal Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. Oversight of Global CRO from a quality perspective and direct Inspection Readiness/Preparation and Inspection Hosting.
Responsibilities:
Qualifications: